The following data is part of a premarket notification filed by Viora Ltd. with the FDA for V10 System.
| Device ID | K150035 |
| 510k Number | K150035 |
| Device Name: | V10 System |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | VIORA LTD. 3 MASKIT STREET Herzlyia, IL 4673303 |
| Contact | Omri Kesler |
| Correspondent | Omri Kesler VIORA LTD. 3 MASKIT STREET Herzlyia, IL 4673303 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-09 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016746419 | K150035 | 000 |
| 07290016746273 | K150035 | 000 |
| 07290016746266 | K150035 | 000 |
| 07290016746259 | K150035 | 000 |
| 07290016746020 | K150035 | 000 |